Z-1292-2018Class II

Uterine Electromyographic Monitor - Monica Novii Wireless Patch System

Name: Z-1292-2018 Uterine Electromyographic Monitor - Monica Novii Wireless Patch System
Creator: GE Healthcare, LLC
Published: 2017-12-15
License: https://open.fda.gov/license/

GE Healthcare / initiated 2017-12-15 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a... on 2017-12-15. FDA classified it as Class II and gives the reason as "if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1292-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-15
Posted: 2018-03-14
Terminated: 2020-04-21
Recalling firm: GE Healthcare
Product: Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is an accessory to the Novii Pod which provides a means of interfacing the wireless output of the Novii Pod to the transducer inputs of a CTG Fetal monitor via three cables. The Novii Interface enables signals collected by the Novii Pod to be printed and displayed on a CTG Fetal Monitor and sent on to a central network, if connected.
Product code: OSP Uterine Electromyographic Monitor
Reason for recall: if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR) signals would be displayed incorrectly (swapped).
Root cause tag: design
FDA root cause: Device Design
Action: GE Healthcare sent an Urgent Medical Device correction Letter dated December 15, 2017 to their customers. The letter identified the affected product, problem and action to be taken. Customers are instructed to: 1. Follow the attached safety instructions to replace the screws, see attached page 2. 2. Follow the attached safety instructions to perform the Monica Novii function TEST to confirm correct cable connection, see attached page 3. 3. If the Monica Novii System fails the Novii function TEST, contact a GE Healthcare Representative to schedule repair/replacement. 4. If the Monica Novii System passes the Novii function TEST, you may continue to use Monica Novii System without any further action. 5. Complete the attached fax back form (page 4&5) for all Monica Novii System as soon as you have completed the screw replacement. If you have any questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative
Quantity in commerce: 1742
Distribution: Worldwide - US Nationwide Distribution.
Product codes and lots: Model # - 107-PT-020 ( all units distributed from January 2016- November 2017)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1292-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1292-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02
Z-1293-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-02

Product code OSP

K140862Class IIMonica Novii Wireless Patch SystemMonica Healthcare, Ltd. / cleared 2014-08-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)